Status:
ACTIVE_NOT_RECRUITING
Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Patients and Their Primary Caregivers
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Malignant Solid Neoplasm
Caregiver
Eligibility:
All Genders
18+ years
Brief Summary
This trial studies the frequency of cachexia in ambulatory cancer patients and the psychological burden in patients and their primary caregivers who are referred to an outpatient supportive care clini...
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the proportion of patients with cancer cachexia, as defined by various criteria including The European Society of Clinical Nutrition and Metabolism (ESPEN) as well a...
Eligibility Criteria
Inclusion
- \[Patient\] Patients visiting the Supportive Care Clinic (SCC) for a consultation or a follow up.
- \[Patient\] Patients who can identify a primary caregiver.
- \[Patient\] Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
- \[Patient\] Be able to read and speak English.
- \[Patient\] 18 years of age or older.
- \[Caregiver\] Be identified or self-identified as a primary caregiver of the patient.
- \[Caregiver\] Provide informed consent
- \[Caregiver\] Be able to read and speak English.
- \[Caregiver\] 18 years of age or older.
- \[Caregiver\] Caregivers who are not able to complete the questionnaire on the day of patients' SCC visit must be willing to engage in a telephone questionnaire with research staff within 60 days of the patient's enrollment.
Exclusion
- \[Patient\] Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- \[Patient\] Patients with no caregiver or only paid caregivers.
- \[Patient\] Patients with cognitive impairment as identified by research staff, treating physician or nurse (Memorial Delirium Assessment Scale score of \>/= 7).
- \[Caregiver\] Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- \[Caregiver\] Not a primary caregiver or is a paid caregiver.
- \[Caregiver\] Evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place
Key Trial Info
Start Date :
June 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT04090619
Start Date
June 22 2021
End Date
December 31 2027
Last Update
August 20 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030